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Full Text of this Amendment

SA 1039. Mr. GRASSLEY submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the end of subtitle E of title II, insert the following:
SEC. 2X. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY.
With respect to all actions of the Food and Drug Administration related to postmarketing drug safety, including labeling changes, postapproval studies, and restrictions on distribution or use of drugs with serious risks, the Office of Surveillance and Epidemiology (or successor office) of such Administration and the Office of New Drugs (or successor office) of such Administration shall make decisions jointly. In the event of a disagreement with respect to an action related to postmarketing drug
safety, including labeling changes, postapproval studies, and restrictions on distribution or use of drugs with serious risks, between such 2 offices, the Commissioner of Food and Drugs shall make the decision with respect to such action.

(As printed in the Congressional Record for the Senate on May 3, 2007.)